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Friday, September 17, 2010

God Save Dynamic Stabilization, Is This Technology on Life Support?

The Sex Pistols once wrote a song entitled, God Save The Queen. By the looks of the latest news, we can rename it God Save The Dynamic Stabilization Market. Based on the latest news release it seems that Applied Spine has retained Gerbsman Partners to solicit interest for the acquisition of all, or substantially all of AST's assets. A private based company with origins in New Haven, Connecticut, AST was going to set the standard for dynamic stabilization. The company had been financed with $47 million over three venture rounds. Just like General Custard at the Battle of Little Bighorn , AST views itself as the "last man standing."

Considering that AST has no fusion labeling and no 510(k) it views itself as the first to market with this device in the United States. Hopefully the investors at Oxford, Bioventures, Interwest, DeNovo, Growth Capital and MB Ventures have all learned a lesson about rolling the dice on a technology that had greater odds than Seabiscuit. Just like Seabiscuit, the Stabilimaxx is tired and sore. If anyone is interested in buying this technology and continuing to develop it, it will take a Tom Smith like trainer to reign in the lack of continuity that this company has experienced. From the beginning, this company was doomed. Tom Woods as CEO, the legendary JP Timms as its VP of R&D. Craig Corrance was hired to do whatever it is that he does to get this to the market. Unfortunately, all other so called dynamic stabilization devices are caught under the FDA's 522 order, which gives the FDA the authority to require a manufacturer to conduct post-market surveillance of a Class II or Class III device that meets their criteria.

In addition to all of these challenges, AST has had to deal with a few failures which originally surfaced during the 2008 NASS meeting in Toronto. Maybe the VC's need to learn to talk to some of the real people in the trenches in this industry. The financial analysts and soothsayers that have permeated this industry have done more harm than good. As far back as 2006, there were engineers that had looked at this product that said, "Panjabi or No Panjabi, this product is never going to get to the market." Looks like Gerbsman and Partners is looking for someone to buy the scalp of AST. Is the Dynamic Stabilization Market dead in the water? TSB wants to know what our readers think?

First off, it's a terrible time to bring a new "back surgery" treatment to market, with the insurance industry having newfound authority to deem anything experimental until the Pope himself declares it divinely inspired. They will do anything possible to trim the number of back surgeries performed, and any indication that something is other than a "run of the mill" discectomy or fusion is, in their mind, a good place to start.

Second, on a clinical level, one challenge the dynamic stabilization market faces, is an unclarity of exactly what to use the technology for. AST is advocating for Lumbar Spinal Stenosis, while Dynesis is for patients " with acute and chronic instabilities caused by degenerative changes in the intervertebral discs." (i.e. DDD) This unclarity isn't exactly in the surgeons' own minds, they know what they want to do with it. But it's an unclear diagnosis for the purposes of research study and communication to the outside world of exactly what it is, what it's for, and how it works. This makes acceptance of its role by skeptical surgeons, and by outsiders, such as the aforementioned payers, a difficult challenge.

Just a bad time to come to market in this newly cost conscous, hyper critical and overscrutinized arena.

It's been said several times before and couldn't be more true - this is a technology looking for an indication. With no substanitive 5 year post-op data and significant cost premiums, this one is circling the drain.

Another one the FDA flat out failed on, and as a result there are people out there walking around with ticking timebombs in thier back.

To Sept 17 1PM, why is dynamic stabilizaiton inherently a ridiculous concept? Are you a surgeon or a sales rep, engineer?

An external corset is a form of dynamic stabilization. Perhaps we can some day come up with an internal form of dynamic stabilization. We have not yet successed but the concept is not inherently flawed in my opinion.

Question: Why do we fuse? In simple terms, to stabilize the spine (which has become unstable iatrogenically or through the degenerative process). How many spine surgeons do you know of who have gotten a lumbar fusion? Precious few. Could that be because they know what we all know -- the long term sequelae of fusions? Dynamic stabilization simply seeks to provide an alternative the stops or slows down what Steffee called "the relentless ascent of the spine." A wise and tenured spine surgeon once said, "Nothing destroys confidence as much as follow up." Spine surgeons who follow their fusion patients long term know what many others won't admit -- fusion solves a short term problem but often creates a much more serious problem down the line. To say "Dynamic Stabilization = bad medicine" simply shows you've drunk the Kool Aid.

Dynamic Stabilization is not = bad medicine; Rather one can agree that it is not matured or established medicine. The Theoretical basis and preclinical data on devices like DSS (Paradigm Spine) and AST's device is quite convincing that kinematic signature of the motion segment can be restored. The problem as I see is that disc degeneration is a progressive disorder. The above devices rely on a progressively ageing disc (anteriorly) to maintain dynamic stabilization (posteriorly). This along with mobilization based at the screwhead-polyurethanetubing junction alone (as with Dynasys) or with a flexi-rod concept (N-Spine) alone will fail. It is important to develop a solution like a "Soft PLIF" wherein a inter-body device support provides the necessary load bearing. One such interbody device is the D3 device developed by Dr Ashish Diwan in Sydney. May be one of the posterior stabilizers can team up with him to provide back pain sufferers a posterior only motion preserving solution which is not kyphogenic like interspinous devices.

Great comments Anonymous 3:19 am (By the way, when do you sleep?). This is the way I look at the subject under discussion: No one has ever discovered the fountain of youth and no one has yet been able to stop the aging process. So when the aging process for an individual means that his/her knee or hip goes bad, do we say, "Tough luck. Live with it." Not exactly. Do we fuse the joint and say, "Live with it." Not exactly. We offer him/her the best alternative means possible of regaining or maintaining a "normal lifestyle.” We preserve motion in the joint even if it doesn’t mean that he/she will be running wind sprints anytime soon. If a spine joint goes bad and we apply the same rationale, doesn’t it make sense to have as our goal not to reverse the aging process, but to address the particular disease which has manifested itself in the aging process for a particular individual with the hope of giving them back something like a "normal life.” I contend that dynamic stabilization = good medicine, at least in theory, because it seeks to retain dynamism while at the same time stabilizing an unstable joint. We can debate whether particular systems available today achieve this goal or not, but just because we have not reached the pinnacle of outcomes, it hardly means that the objective is unworthy or illegitimate.

I have a stabilimax "installed 2.5 yrs. ago. siatica releived , BUT nothing but low and mid back pain since. Can't get a straight answer out of my doctor and am out of work now with no chance of future income in site because of the pain. Now they are selling the company, to get out of the responsability of it all. Im getting a lawyer.

Forget the lawyer get another surgeon. often it is the residual pain generator that is the cause of ongoing pain either at the same level or level above/below. The device itself may not be responsible unless they are implanted poorly.